Home NDC 0078-0357 Trileptal
Product NDC 0078-0357
11-digit product format 000780357
Labeler code 0078
Product ID 0078-0357_dcd739ce-e938-40e6-8912-ca4f34b49cf3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA021285
Marketing category NDA
Marketing start 2001-05-30
Substance OXCARBAZEPINE
Active strength 60 mg/mL
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021285-001 TRILEPTAL OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021285-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021285-001 8119148*PED 2021-06-19 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021285-001 8119148*PED 2021-06-19 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021285-001 8119148*PED 2021-06-19 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021285-001 8119148*PED 2021-06-19 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021285-001 8119148*PED 2021-06-19 Pediatric extension ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Trileptal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VZI5B1W380 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 261356 Internal RxNorm lookup 261360 Internal RxNorm lookup 262090 Internal RxNorm lookup 283536 Internal RxNorm lookup 312136 Internal RxNorm lookup 312137 Internal RxNorm lookup 312138 Internal RxNorm lookup 351992 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0357-52 Trileptal 250 mL in 1 BOTTLE SUSPENSION 250 39
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 LEMON INACTIVE INGREDIENT 24RS0A988O TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 PLUM INACTIVE INGREDIENT 67M3EQ6BE1 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SORBIC ACID INACTIVE INGREDIENT X045WJ989B TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SORBITOL INACTIVE INGREDIENT 506T60A25R TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 TALC INACTIVE INGREDIENT 7SEV7J4R1U TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 WATER INACTIVE INGREDIENT 059QF0KO0R TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0357 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 37 Current NDC, Legacy NDC, 1 package rows 20250122_4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0357-52 00078035752 250 mL in 1 BOTTLE (0078-0357-52) 250 ml 2001-05-30 0000-00-00 No No Current